United States Environmental Protection Agency Office of Chemical Safety

and Pollution Prevention (7101) EPA 712-C-12-027 April 2012



# Microbial Pesticide

Test Guidelines

OCSPP 885.1250: Deposition of a Sample in a Nationally Recognized

Culture Collectioni NOTICE

This guideline is one of a series of te st guidelines established by the United States Environmental Protection Agency’s O ffice of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesti cides and chemical substances to develop data for submission to the Agency under the To xic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq. ), the Federal Insecticide, F ungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq. ), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides, and Toxic Subst ances (OPPTS). To distinguish these guidelines from guidelines issued by other organizations , the numbering convention adopted in 1994 specifically incl uded OPPTS as part of the guideline’s number. Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in

their title.

The OCSPP test guidelines serve as a compendium of accepted scientific methodologies and protocols that are int ended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. This document provides guidance for conducting the test, and is also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or FFDCA. As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guid elines where circum stances warrant and without prior notice. At places in this gui dance, the Agency used the word “should.” In this guidance, the use of “should” with regar d to an action means that the action is recommended rather than mandatory. The pr ocedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropria te in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropria teness on a case-by-case basis.

For additional information about OCSPP harmonized test guidelines and to access the guidelines electronically, please go to http://www.epa.gov/ocspp and select

“Test Methods & Guidelines” on the navi gation menu. You may also access the guidelines in http://www.regulations.gov , where they are grouped by Series under

Docket Identification Numbers EPA- HQ-OPPT-2009-0150 through EPA-HQ-OPPT2009-0159, and EPA-HQ-OPPT-2009-0576.1 OCSPP 885.1250: Deposition of a sample in a nationally recognized culture

collection

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(a) Scope —

(1) Applicability. This guideline is intended to me et testing requirements of the Federal Insecticide, Fungicide, and R odenticide Act (FIFRA) (7 U.S.C. 136, et seq. ).

(2) Background. The original data requirements for microbial pesticides, as promulgated in 1984 ( 49 FR 42856, October 24, 1984) , include a conditional requirement for submission of microbial pesticide samples to an EPA repository in Beltsville, Maryland. This continues to be a conditional requirement for chemical pesticides, but it was soon recognized that the EPA pesticide repository did not have the special equipment and expertise to properly preserve these living organisms. This data requirement, however, was not clarifi ed until the Part 158 data requirements for biochemical and microbial pesticides were revised and published in 2007 (72 FR 60988, October 26, 2007). In the preamble to t he proposed rule for these revised data requirements (71 FR 12072, March 8, 2006) , EPA explained that the submittal of samples data requirement had been replaced by the requirement to maintain a sample in a nationally recognized culture collection:

Submittal of samples . This provision is typi cally intended to enable EPA to identify the active ingredient and provide st andards to governmental agencies needing to monitor chemical pesticide residues and is conditionally required (CR). The Agency proposes to require (R) these data as a product analysis requirement to be deposited in a nationally recognized culture collection to allow EPA to validate strain identity if issues arise (gui deline 885.1200).

Since the Agency does not have capacity to store the variety of microbial pesticides that may be submitted, EPA did not set up a nationally recognized culture collection. Ther e are several nationally recognized culture collections in this country ( and abroad) such as the American Type Culture Collection (ATCC) and a microbial collecti on maintained in Peoria, Ill., by the USDA. These facilities have a vast number of microbial and cell cultures that [the facilit ies] are dedicated to transferring, maintaining and identifying. Rather than duplicate this effort, EPA chose to refer microbial pesticide producers to these facilities who have the routine expertise to keep and distribute (or protect) microbi al cultures. There is a certain element of required expertise but really the cost and small number of our microbial pesticides would make it prohibitively expensive for the Agency

to do this collection rather than direct the companies to these specialized

facilities.

This new guideline (885.1250) also includes information, taken from OCSPP guidance for specific products, to better ex plain how to best “maintain a sample on2 deposit in a nationally recogni zed culture collection.” Be cause of the potential for microorganisms to gain or lose active pesti cidal properties, or to acquire other risk

factors due to mutations or due to natural transfer or loss of genetic material, it is essential that each microbial pesticide acti ve ingredient be identified uniquely and deposited in a culture collection by the registrant of that mi crobial pesticide. This will enable the Agency to determine whether market ed pesticides vary from the original source microorganism and to hold the regi strant accountable for the product composition, where appropriate.

3) Source. The source material originally used in developing harmonized OPPTS test guideline 885.1200, from which this guideline (885.1250) was taken, is OPP guideline 151A–11, as publis hed in July 1989.

(b) Maintenance of samples. A sample of each registered microbial pesticide active ingredient is to be maintained on deposit in a nationally re cognized culture collection. The sample of the active ingredient w ould best be deposited as a culture with a maintenance agreement, such as in the American Type Culture Collection (ATCC) Patent Collection, so that there is no chance t he culture collection will discard it. It is the responsibility of the registrant to ensure that its active i ngredient remains on deposit as long as it maintains the registration or ex perimental use permit associated with that microbial pesticide active i ngredient. If it is no longer in a culture collection, the registrant must rede posit a sample that is represent ative of the isolate that was originally registered and not ify the Agency of the new num ber. The deposition number

would be included in the Conf idential Statement of Formula . This number, however,

would not have to be on the label unless it is also used as the co mpany unique identifier for the microbial pesticide active ingredient . The culture collection deposit does not have to be available to the public for obt aining a sample, but a sample must be

available to be sent to EPA, if requested.

Article 6 of the Budapest Tr eaty on the International Rec ognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (Budapest Treaty, 1980) provides information on what would constitute a “recogni zed” culture collection that would provide assurance for continuing main tenance of a culture deposit:

(1) Have a continuous existence; (2) Have the necessary staff and facilities, as prescribed in the Regulations, to perform its scientific a nd administrative tasks under this Treaty; (3) Be impartial and objective; (4) Be available, for the purposes of deposit, to any depositor under the same conditions; (5) Accept for deposit any or certain kinds of microorganisms, examine their viability and store them, as pr escribed in the Regulations; (6) Issue a receipt to the depositor, and any required viabi lity statement, as prescribed in the Regulations; (7) Comply, in respect of the deposited microorganisms, with t he requirement of secrecy, as prescribed in the Regulations;3 (8) Furnish samples of any deposited mi croorganism under the conditions and in conformity with the procedure pr escribed in the Regulations.

(c) Reference. Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. D one at Budapest on April 28, 1977 and amended on September 26, 1980. Available from the World Intellectual Property Organization at http://www.wipo.int/

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